leflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Leflunomide.
| Product ID | 70710-1157_c9906419-d11a-4520-9f2d-88b94e622fe5 |
| NDC | 70710-1157 |
| Product Type | Human Prescription Drug |
| Proprietary Name | leflunomide |
| Generic Name | Leflunomide |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-04-26 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA212308 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | LEFLUNOMIDE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Antirheumatic Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-04-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA212308 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-04-26 |
| Marketing Category | ANDA |
| Application Number | ANDA212308 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-26 |
| Marketing Category | ANDA |
| Application Number | ANDA212308 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-26 |
| Ingredient | Strength |
|---|---|
| LEFLUNOMIDE | 10 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0955-1735 | Leflunomide | leflunomide |
| 0955-1737 | Leflunomide | leflunomide |
| 10702-277 | Leflunomide | Leflunomide |
| 10702-278 | Leflunomide | Leflunomide |
| 13811-677 | Leflunomide | Leflunomide |
| 13811-678 | Leflunomide | Leflunomide |
| 23155-043 | Leflunomide | Leflunomide |
| 68258-2992 | Leflunomide | Leflunomide |
| 23155-044 | Leflunomide | Leflunomide |
| 46708-437 | Leflunomide | Leflunomide |
| 46708-436 | Leflunomide | Leflunomide |
| 60505-2503 | LEFLUNOMIDE | LEFLUNOMIDE |
| 60505-2502 | LEFLUNOMIDE | LEFLUNOMIDE |
| 62332-062 | Leflunomide | Leflunomide |
| 62332-061 | Leflunomide | Leflunomide |
| 70710-1157 | leflunomide | leflunomide |
| 70710-1158 | leflunomide | leflunomide |
| 70771-1492 | leflunomide | leflunomide |
| 70771-1491 | leflunomide | leflunomide |
| 42291-420 | LEFLUNOMIDE | LEFLUNOMIDE |
| 42291-421 | LEFLUNOMIDE | LEFLUNOMIDE |
| 70748-130 | Leflunomide | Leflunomide |
| 70748-129 | Leflunomide | Leflunomide |
| 50268-477 | LEFLUNOMIDE | LEFLUNOMIDE |
| 50268-478 | LEFLUNOMIDE | LEFLUNOMIDE |
| 0088-2160 | Arava | leflunomide |
| 0088-2161 | Arava | leflunomide |
| 0088-2162 | Arava | leflunomide |